Scopolamine Treatment for Patients With Organophosphate Poisoning (NCT00389259) | Clinical Trial Compass
WithdrawnNot Applicable
Scopolamine Treatment for Patients With Organophosphate Poisoning
Israel50 participantsStarted 2007-10
Plain-language summary
Organophosphate (OP) compounds are a major threat as chemical warfare agents or in terrorist act. OPs are also the active ingredient of many insecticides. Ingestion of insecticides is a common cause of death among people who commit suicide in developing countries. OPs poisoning also frequently occurs after accidental exposure to agricultural OPs and in children as a result of unintentional ingestion.
The use of competitive inhibitors of acetylcholine other than atropine for patient with organophosphate (OP) poisoning is controversial. Because scopolamines' ability to cross the blood brain barrier is better than atropine, it has been suggested that scopolamine should be used OP poisoned patients who have central nervous system (CNS) manifestations. However there is controversy regarding its potential benefit in the treatment of organophosphate poisoning in humans. To the best of our knowledge there are no randomised controlled studies on the use of scopolamine in humans. This prospective randomised controlled study is aimed to determine whether adding scopolamine to the standard treatment of atropine and oximes in patients with CNS symptoms of OP poisoning improve the outcome.
Who can participate
Age range
2 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age: 2- 60 years
* At least two of the following three criteria:
* Known exposure to an organophosphate or carbamate insecticide in the last 72 hours.
* Symptoms and signs typical to organophosphate poisoning involving at least two systems (gastrointestinal, respiratory, skin, eyes,) See appendix
* Low levels of plasma butyrylcholinesterase (less than 50% of the lower normal range )
* CNS involvement in the first 72 hours after exposure: determined by finding at least one of the following major criteria or at least two of the minor criteria
Major criteria for CNS involvement:
* Seizures
* Extrapyramidal or Parkinson like symptoms
* Decreased level of consciousness (GCS\< 12)
Minor criteria for CNS involvement:
* GCS 14-12
* Confusion
* Hallucinations
Exclusion Criteria:
* Hypersensitivity to scopolamine
* Glaucoma, narrow-angle (angle-closure)
* Tachyarrhythmias, congestive heart failure
* Obstructive gastrointestinal disease
* Myasthenia Gravis
* Reflux esophagitis
* Ulcerative colitis
* Known obstructive uropathy
* Pregnancy
* Patient or legal guardian unable to give informed consent (see comment under ethics)
* Severe co-morbidity (multi-trauma, advanced cancer, etc)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Improvement in neurological status as measured by the Glasgow Coma Scale